1,5 Anhydroglucitol and 1,5 Anhydroglucitol / Glycated Hemoglobin Ratio as a Potential Biomarker for Islet β-cell Function and Insulin Resistance Among Patients With Type 2 Diabetes Mellitus

NCT ID: NCT04869605

Last Updated: 2022-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-06
• Study Completion Date: 2022-10-31

Brief Summary

Hyperglycemia is a major risk factor for the micro- and macro-vascular complications of diabetes . Lowering blood glucose levels has been shown to reduce the incidence of diabetes complications.

Therefore, there is a need for a simple surrogate biochemical marker for glycemic variability. Glycated hemoglobin (HbA1c) is the standard clinical measurement used to monitor glycemic status and is recommended to assess control of diabetes over the preceding 2-3 months. However, being a measure of mean glucose, it does not reflect glucose variability.

It is well known that insulin secretion defects of islet β cells and/or tissue insensitivity to insulin are common pathophysiological mechanisms of diabetes mellitus (DM) .

The elevation in the blood glucose level usually represents the degree of glucose metabolism disorder, which is generally assessed by glycated hemoglobin A1c ( HbA1c) and indirectly reflects the extent of β-cell function damage .

In the recent years, 1,5-anhydroglucitol (1,5-AG) has received attention as a short-term blood glucose index that reflects the average blood glucose level 1,5 AG reflects the average maximum blood glucose level during the past 1-2 weeks and is reported to be a more sensitive marker of glucose variability and postprandial hyperglycemia than HbA1c, even for patients with prediabetes and for those with well or moderately controlled diabetes .

(1,5 AG ) is structurally similar to glucose . Due to this similarity, glucose inhibits renal reabsorption of 1,5 AG by competitive inhibition ,resulting in an inverse correlation of 1,5 AG with hyperglycemia .

1,5-AG levels are acting as an effective supplement to HbA1c. Additionally, previous study showed that 1,5-AG and HbA1c had opposite curves with increasing blood glucose levels; specifically, with the increase in HbA1c levels, 1,5-AG levels decreased significantly . Therefore, we speculate a ratio of 1,5- AG / HB A1C in relation to islet β-cell function and insulin resistance.

The aim of our study was to evaluate the role of 1,5 anhydroglucitol and 1,5 anhydroglucitol / HbA1c ratio as a potential biomarker for islet β-cell function and insulin resistance among patients with type 2 diabetes .

Conditions

Diabetes Mellitus

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Interventions

1,5 Anhydroglucitol and 1,5 Anhydroglucitol / Glycated Hemoglobin ratio

the role of 1,5 anhydroglucitol and 1,5 anhydroglucitol / HbA1c ratio as a potential biomarker for islet β-cell function and insulin resistance among patients with type 2 diabetes

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Men and women aged 20 to 70 years old with controlled and uncontrolled type 2 DM.

Exclusion Criteria

• : type 1 DM,
• thyroid dysfunction,
• chronic kidney disease,
• chronic liver disease,
• cancer patients,
• cystic fibrosis,
• acute and chronic infection and
• pregnancy

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mona Youssry Helmy

Lecturer of internal medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, Manial, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Nehal H Elsaid

Role: CONTACT

nihalhamdyelsaid@yahoo.com

01004389020 ext. 02

Facility Contacts

Mona Youssry, M.D.

Role: primary

mona55508@yahoo.com

01004389020 ext. 01004389020

References

-Janssen J, van den Berg E, Zinman B , Espeland MA , Geijselaers S LC et al., (2019) . HbA(1c), insulin resistance, and β-cell function in relation to cognitive function in type 2 diabetes: the CAROLINA Cognition Substudy. Diabetes Care 42(1):e1-e3. -Kanat M, Winnier D, Norton L, Arar N, Jenkinson C, Defronzo RA et al ., (2011) . The relationship between {beta}-cell function and glycated hemoglobin: results from the veterans administration genetic epidemiology study. Diabetes Care. 2011 Apr;34(4):1006-10. -Kim MJ, Jung HS, Hwang-Bo Y, Cho SW, Jang HC, Kim SY et al ., (2013) . Evaluation of 1,5-anhydroglucitol as a marker for glycemic variability in patients with type 2 diabetes mellitus. Acta Diabetol. 2013;50:505-10.

Reference Type: BACKGROUND

Other Identifiers

N-26-2021

Identifier Type: -

Identifier Source: org_study_id